American Association of Homeopathic Pharmacists
5112 Wilshire Drive
Santa Rosa, CA 95404
The American Association of Homeopathic Pharmacists
Presented a Compliance Through Education:
Homeopathic OTC Drug Labeling Seminar
The fourth A.A.H.P. Compliance Through Education seminar: Homeopathic OTC Drug Labeling coincided with the Natural Products ExpoEast in Baltimore, on October 20 and 21, 1999.
The two-day course specifically addressed the requirements for OTC homeopathic drug products: both the requirements of the FDA Compliance Policy Guide for Homeopathic Drug products, and the just published final regulations for OTC Drug Labeling. The seminar was an invaluable help for all manufacturers' and distributors' understanding of FDA's authority, regulations and the policies for labeling and advertising of homeopathic drug products.
When A.A.H.P. Board members met with the agency, FDA officials expressed continuing concern regarding non-compliant homeopathic labeling and products. Mr. Miracco (of FDA's Nontraditional Drug Compliance team) reiterated these concerns again at least three times during his presentation at the A.A.H.P. 75th Anniversary Evening. FDA's enforcement activities in this area remain troublesome for homeopathic manufacturers and distributors. FTC and FDA are increasing their scrutiny of homeopathic drug advertising.
Seminar participants were able to identify important issues in label and advertising copy and became familiar with the requirements for compliant labeling. Managers and executives responsible for labeling and advertising all found the course content beneficial in their daily work. The included hands-on workshop gave participants an opportunity to use the material with immediate constructive feedback from Alvin J. Lorman, the seminar leader.
Topics covered in the 2 day seminar included:
- Introduction to Labeling and Advertising Regulations
- FDA Prescription Labeling Policies and Regulations
- FDA OTC Labeling Policies and Regulations
- FDA & FTC Advertising Review Process
- Drug Advertising
- FDA Regulatory Actions on Advertising
- Review of Recent FDA Policies and Decisions Concerning Advertising
- Internal Corporate Review and Policies for Labeling and Advertising
- Workshop - Building a Compliant Homeopathic Drug Label
Mr. Alvin J. Lorman was chosen as seminar leader for his long experience with homeopathic products. Mr. Lorman is an attorney with the Mintz, Levin, Cohn, Ferris, Glosvsky and Popeo firm in Washington, D.C. and has represented numerous domestic and oversees homeopathic companies over the past 15 years. On behalf of the homeopathic industry, he successfully negotiated with FDA for issuance of the Compliance Policy Guide which regulates the sale of homeopathic drugs in the United States. He has worked with the H.P.C.U.S. and A.A.H.P. in the past and is a recognized legal authority for homeopathic issues. He also maintains an active practice before the E.P.A., F.T.C. and O.S.H.A. The choice of Mr. Lorman will ensure the seminar is a valuable investment for your company's regulatory compliance program.
Seminar space was limited to the first 30 paid registrants. The cost of this special seminar was only $875 for each A.A.H.P. Member company registrant, which includes materials and breaks. Non-Member companies were invited to participate for $925 per registrant. (Compare this to the cost of a standard course which has no homeopathic product information!)